Generic DOJOLVI entry is pushed to 2033, removing a key overhang. Monitor resolution of remaining ANDA litigations and any FTC/DOJ review of the settlement.
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Executive Summary
Ultragenyx settled patent litigation with Navinta LLC over DOJOLVI (triheptanoin), granting Navinta a royalty-free license to market a generic version beginning January 1, 2033 (or July 1, 2033 if pediatric exclusivity is granted). The settlement removes near-term generic risk but establishes a clear generic entry date. Similar litigation against other ANDA filers remains pending.
Key Facts
- Settlement with Navinta LLC resolves patent litigation over DOJOLVI (triheptanoin) oral liquid.
- Navinta receives a non-exclusive, royalty-free license to market generic DOJOLVI beginning January 1, 2033.
- License start date extends to July 1, 2033 if pediatric exclusivity is granted for DOJOLVI.
- Similar patent litigation against other ANDA filers remains pending in the U.S. District Court for the District of New Jersey.
- Settlement agreement will be submitted to the U.S. Federal Trade Commission and the U.S. Department of Justice.
Financial Impact
No financial terms disclosed; generic entry delayed until at least 2033, preserving DOJOLVI revenue exclusivity for approximately 6+ years.
Risk Factors
- Remaining ANDA litigations could result in earlier generic entry if not settled on similar terms.
- FTC/DOJ review could challenge the settlement if deemed anticompetitive.
- Pediatric exclusivity decision could shift generic entry date by six months.
Investment Themes
Documents Analyzed
This report is based on 3 SEC documents filed with EDGAR.
| Document | Accession Number |
|---|---|
| 8-K Filing (Primary) | 0001193125-26-424739 |
| Document: 0001193125-26-424739-index.html | 0001193125-26-424739 |
| Document: 0001193125-26-424739.txt | 0001193125-26-424739 |
Filters
| Type | Now | ||||
|---|---|---|---|---|---|
Oct 20, 2026 7d ago | SC 13G | $15.92 | awaiting T+5 | — | $16.08 (+1.01%) |
Oct 19, 2026 8d ago | 8-K | $15.07 $16.08 | ▲ +6.70% | ▲ +6.85% | $16.08 (+6.70%) |
Oct 14, 2026 13d ago | 8-K | $14.90 $15.92 | ▲ +6.85% | ▲ +6.39% | $16.08 (+7.92%) |
Oct 7, 2026 20d ago | 8-K | $14.89 $14.90 | ▲ +0.07% | ▲ +1.05% | $16.08 (+7.99%) |
Sep 17, 2026 5w ago | Press Release | $14.50 $14.77 | ▲ +1.86% | ▲ +1.01% | $16.08 (+10.90%) |
Sep 2, 2026 7w ago | 8-K | $14.85 $14.30 | ▲ +3.70% | ▲ +2.56% | $16.08 (−8.28%) |
Sep 1, 2026 8w ago | Press Release | $26.53 $14.40 | ▼ −45.72% | ▼ −44.76% | $16.08 (−39.39%) |
Aug 11, 2026 11w ago | 8-K | $26.80 $25.49 | ▼ −4.89% | ▼ −4.48% | $16.08 (−40.00%) |
Aug 4, 2026 12w ago | 8-K | $24.93 $26.86 | ▲ +7.74% | ▲ +7.39% | $16.08 (−35.50%) |
Aug 4, 2026 12w ago | Insider Cluster | $25.81 $26.96 | ▲ +4.46% | ▲ +4.56% | $16.08 (−37.70%) |
US Market Status
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